PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

1. Personalize treatment for prostate cancer based on how aggressive the disease is and 2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy.

Eligibility criteria

Qualifiers

Histologically confirmed prostate cancer.

PSA ≥ 0.1 after radical prostatectomy.

Candidate for salvage radiation and ADT treatment, as determined by treating physician.

Age >18 at the time of consent.

Disqualifiers

Use of post-prostatectomy testosterone suppression prior to registration (use of GnRH agonist or antagonist, with or without an anti-androgen). However, participants with testosterone recovery after post-prostatectomy testosterone suppression are eligible (testosterone recovery defined as total testosterone > 190 ng/dL) regardless of how long their testosterone was suppressed.

Use of testosterone suppression prior to prostatectomy if the ArteraAI Prostate Test (Post-RP) is required to risk stratify patients (those patients with PSA ≤0.5 and no evidence of nodal involvement require ArteraAI Prostate Test (Post-RP) to stratify).

Confirmed extrapelvic or bone disease based on conventional imaging

Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy).

Trial design

Treatments tested in this trial

  • Apalutamide
  • Androgen Deprivation Therapy

Treatment groups

120 Participants
are divided into 4 treatment groups

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

Janssen Scientific Affairs, LLC

Collaborator